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临床试验/2025-520637-24-00
2025-520637-24-00招募中2 期

Use of a new diagnostic tool in the detection and characterization of endometriosis lesions. ENDO-TEP

Centre Hospitalier Universitaire De Toulouse1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年5月23日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
20
试验地点
1
主要终点
Characterization of the hypermetabolism of lesions on PET by analysis of SUV: Hypermetabolism present or not and quantification

研究概览

简要总结

The main objective is to study the use of a new diagnostic tool: [18F]-FES PET/CT in the detection and characterisation of endometriosis lesions in association with pain.

入排标准

年龄范围
18 years 至 64 years(18-64 Years)
性别
Female
接受健康志愿者

入选标准

  • Test: Painful patients with VAS ≥ 4 treated surgically for painful symptoms related to endometriosis
  • Control: Patient with VAS < 4 treated surgically for endometriosis in the context of infertility
  • Age > 18 years old
  • Patient with informed consent
  • Patients with preoperative MRI not contraindicated for [18F]-FES PET/CT
  • Patient operated on mid-cycle
  • Membership of a Social Security scheme

排除标准

  • Patient treated for endometriosis without surgery
  • Pregnant patient
  • Claustrophobic patient
  • Hypersensitivity to the active substance (Fluoroestradiol(18F)) or to one of the excipients
  • Patient under legal protection
  • Patient taking hormonal treatment
  • Menopausal patient

结局指标

主要结局

Characterization of the hypermetabolism of lesions on PET by analysis of SUV: Hypermetabolism present or not and quantification

Characterization of the hypermetabolism of lesions on PET by analysis of SUV: Hypermetabolism present or not and quantification

次要结局

  • Analyzes of lesions in Immunohistochemistry (IHC) and results of in situ hybridization: Characterization of the markings (intensity, type of receptor expressed, etc.) for each lesion depending on the anatomical location.
  • Analyzes of lesions in Immunohistochemistry and results of in situ hybridization: Characterization of the markings (intensity, type of receptor expressed, etc.) for each patient according to pain (VAS)
  • Sensitivity of [18F]-FES PET/CT compared to that of MRI in the diagnosis of superficial and deep endometriosis lesions and according to their location
  • Degree of association between [18F] SUV intensity and ER expression (IHC) and pain intensity (VAS)

研究者

申办方类型
Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

Ariane WEYL

Scientific

Centre Hospitalier Universitaire De Toulouse

研究点 (1)

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